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EP3030099B1 - Joint d'étanchéité pour masque facial destiné à être utilisé avec des dispositifs respiratoires et des masques chirurgicaux, à géométrie définie de manière anatomique conformément à des régions critiques de l'anatomie faciale humaine, et pouvant être adapté sur mesure et de manière active au visage de l'utilisateur - Google Patents

Joint d'étanchéité pour masque facial destiné à être utilisé avec des dispositifs respiratoires et des masques chirurgicaux, à géométrie définie de manière anatomique conformément à des régions critiques de l'anatomie faciale humaine, et pouvant être adapté sur mesure et de manière active au visage de l'utilisateur Download PDF

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Publication number
EP3030099B1
EP3030099B1 EP14752518.2A EP14752518A EP3030099B1 EP 3030099 B1 EP3030099 B1 EP 3030099B1 EP 14752518 A EP14752518 A EP 14752518A EP 3030099 B1 EP3030099 B1 EP 3030099B1
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EP
European Patent Office
Prior art keywords
face
mask
seal
respirator
wearer
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP14752518.2A
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German (de)
English (en)
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EP3030099A1 (fr
Inventor
Richard H. Koehler
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KOEHLER, RICHARD H.
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Individual
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Publication of EP3030099A1 publication Critical patent/EP3030099A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B23/00—Filters for breathing-protection purposes
    • A62B23/02—Filters for breathing-protection purposes for respirators
    • A62B23/025—Filters for breathing-protection purposes for respirators the filter having substantially the shape of a mask
    • A—HUMAN NECESSITIES
    • A41—WEARING APPAREL
    • A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
    • A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
    • A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
    • A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
    • A41D13/1107—Protective face masks, e.g. for surgical use, or for use in foul atmospheres characterised by their shape
    • A41D13/1138—Protective face masks, e.g. for surgical use, or for use in foul atmospheres characterised by their shape with a cup configuration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0605—Means for improving the adaptation of the mask to the patient
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/02—Masks
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/02—Masks
    • A62B18/025—Halfmasks
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
    • A62B18/082—Assembling eyepieces, lenses or vision-correction means in or on gas-masks
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B18/00—Breathing masks or helmets, e.g. affording protection against chemical agents or for use at high altitudes or incorporating a pump or compressor for reducing the inhalation effort
    • A62B18/08—Component parts for gas-masks or gas-helmets, e.g. windows, straps, speech transmitters, signal-devices
    • A62B18/084—Means for fastening gas-masks to heads or helmets
    • A—HUMAN NECESSITIES
    • A62—LIFE-SAVING; FIRE-FIGHTING
    • A62B—DEVICES, APPARATUS OR METHODS FOR LIFE-SAVING
    • A62B23/00—Filters for breathing-protection purposes
    • A62B23/02—Filters for breathing-protection purposes for respirators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M2016/0661—Respiratory or anaesthetic masks with customised shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10—Methods of surface bonding and/or assembly therefor
    • Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
    • Y10T156/1043—Subsequent to assembly

Definitions

  • the present invention relates to face seals (FS) for filtering facemask respirators (FFR), and specifically to minimizing FS inward leakage (FSIL) that occurs in FFRs.
  • FS face seals
  • FSIL FS inward leakage
  • Filtering face piece respirators play a critical role in everyday life. They are available for purchase to the general public in most hardware stores and are recommended, or required, for use in a wide variety of home, public, and occupational environments---especially in healthcare settings. Their principle function is to provide respiratory protection against both non-biological and biological particulate materials.
  • FFRs are used generally to protect the wearer.
  • FFRs must function both to protect the wearer from potentially harmful particulate matter, including biological pathogens, and/or to protect populations from a wearer exhaling such pathogens into the environment.
  • the smoke plume generated from electrosurgical use has been shown to contain a wide variety of vaporized viral organisms capable of infection, including HIV and Human Papilloma Virus (HPV).
  • HPV Human Papilloma Virus
  • FFRs In certain public health settings, FFRs must be able to effectively protect the wearer and/or the surrounding human contacts from biological organisms in a wide range of sizes: from large bacteria at .300 to 1.0 micros, to the H7N7 and H7N9 Asian flu virion, where the particle size can be as small as 40-80 nanometers.
  • any FFR that provide its intended protection to the user are: 1) the filter element itself, and 2) the mechanism of sealing the mask to the wearer's face.
  • FFRs are certified by the National Institutes of Occupational Safety and Health's (NIOSH) approval regulation 42 CFR 84, to provide a variety of levels of protection. These NIOSH ratings range from having 95% efficiency at filtering non-oil based aerosolized particulate matter (N95), to 100% efficiency (P100) in filtering particulate matter that is oil-based where the filter itself must be strongly resistant to oil. Volatile organic compounds (VOCs) and other such vapor hazards require half face or full face elastomeric respirators with specific cartridge-based filters (OV/P100), which are commonly referred to as "gas masks”.
  • VOCs volatile organic compounds
  • OVCs half face or full face elastomeric respirators with specific cartridge-based filters
  • NIOSH certification of FFRs has been a major advance in the development and classification of effective filters for FFRs.
  • FSIL has been shown to occur in virtually all N95 FFRs and is dependent on multiple factors including: overall design of the FFR; FS design and the material used; the mechanism of attachment of the FFR to the wearer's face; and the particle sizes being filtered.
  • the protection factor (PF) of the FFR can drop significantly: the reduction of protection due to FSIL in some N95 FFRs has been shown to be up to a 90% failure to filter out sub-micron size aerosolized particles. This is true for particle sizes less than .300 ⁇ m, which includes many viruses in the size ranges of 40-120 nanometers, in particular the Swine flu and Avian flu viruses.
  • FSIL creates a unique problem for healthcare workers in operating room settings on two fronts: The first is that a smoke plume is generated during the customary widespread use of electrocautery during surgical procedures. OSHA estimates that 500,000 workers are exposed to laser and electrocautery smoke each year. Electrocautery creates particles with the smallest mean aerodynamic size of 0.07 ⁇ m-far smaller than the filtering capability of a N95 FFR. Studies have shown that a range of aerosolized toxins are present, including multiple volatile organic compounds that are either known, or suspected, carcinogens. Intact strands of human papillomavirus DNA have been isolated from carbon dioxide laser plumes during treatment of plantar warts and recurrent respiratory papillomatosis. Viable bacteriophage have also been demonstrated to be present in laser plumes. Whole intact virions have been found and their infectivity demonstrated. HIV DNA has been identified in laser smoke, and has also been shown to be capable of transmitting infections into cultured cells.
  • Another very common design in an effort to improve the FS at the nasal bridge section, is to include a malleable nose clip or bar that is secured on the outer face of the mask body centrally adjacent to its upper edge to enable the mask to be deformed or shaped in this region in order to obtain a better fit along what is commonly referred to as the "bridge" of the nose.
  • Such nose bars, or clips are well known to those reasonably skilled in the prior art.
  • a nose clip is described in U.S. Pat. Nos. 5,558,089 (Castiglione ), Pat. App, 2011/006770 (Spoo ) and 5,307,796 (Kronzer ). These are just a few such examples of the prior art.
  • Such nose clips are also commonly associated with a strip of foam affixed to the length of the clip, typically made from materials of either polystyrene, polyester, or neoprene. Examples of such foam strips are described in U.S. Pat. 5,765,556 (Bronson ), and U.S. Pat. App. 2005/0211251 (Henderson ).
  • U.S. Pat. 8,171,933 (Xue ) which describes a preformed nose clip that follows a general curve off the nasal bridge to the sides, exerting a force resiliently inward on each side of the wearer's nose when the mask is worn. This feature is claimed to eliminate the need for the wearer to individually shape the nose clip to the wearer's face.
  • 2008/0023006 which also describes a mask body where at least the first major surface of the nose foam has a predetermined concave curvature, which is claimed to have less opportunity to become pinched or unnecessarily deformed before being placed on wearer's face.
  • the foam strip in these examples only involves the nasal portion of the FS perimeter; it has no inward convex protrusions to address the rest of the entire FS perimeter; and in that it does not involve any specific anatomically defined inner perimeter convex accentuations of the FS that conform specifically to the critical fit zones (CFZs) of the human face as described herein, and as will be further described in the illustrations below of the present invention.
  • U.S. Pat. App. 2008/0099022 (Gebrewold ), which describes a respiratory mask that has a nose foam that has a particular preconfigured shape for assisting in providing a snug fit over the wearer's nose.
  • the nose foam has a nose-contacting surface that is skewed at first and second angles to a plane that extends to the nose foam. It is also claimed that the fit may be able to be achieved without use of a nose clip.
  • this device differs substantially from the present invention in that the design feature described does not address the entire 360 degrees of the FS perimeter, and in that it does not involve any other specific anatomically defined inner perimeter convex accentuations of the FS that conform specifically to the CFZs of the human face as described herein, and as further described in the illustrations below of the present invention.
  • Another design feature to improve the FS fit is to include a vapor seal either across the top portion of the mask to assist in preventing fogging of the mask, or around the entire perimeter of the mask.
  • U.S. Pat. 5,383,438 (Raines ) is an example of such a design feature, as is U.S. Pat. 5,553,608 (Reese ), which describes a stretchable material around the mask.
  • U.S. Pat. 5,553,608 Reese
  • These features differ substantially from the present invention in that the FS design in these examples has no specific anatomically defined inner perimeter convex accentuations that conform specifically to the CFZs of the human face as described herein, and as further described in the illustrations below of the present invention.
  • Another design feature of face masks and FFRs of the prior art, in order to improve the FS fit to the user's face, is to utilize different materials than other such masks of the prior art.
  • One such example is U.S. Pat. App. 2007/0039620 (Sustello ), which uses an expandable or compressible material, such as a viscoelastic foam, or other such materials with similar characteristics, to enhance a seal between the mask and a user's face in an area extending over the bridge of the nose and generally under the eyes.
  • US-A-2012/0017911 (Choi ), which describes a mask housing that is made entirely of a closed cell foam layer that has a plurality of fluid permeable openings located therein.
  • the closed cell foam shaping layer is claimed to provide a sufficient degree of pliability at the perimeter, and is also claimed to enable the mask body to fit comfortably and snugly on a wearer's face without attachment or use of an elastomeric face seal, nose foam, or nose clip.
  • this device does not involve any specific anatomically defined inner perimeter convex accentuations of the FS that conform specifically to the CFZs of the human face as described herein, and as further described in the illustrations below of the present invention.
  • Each of WO-A-00/20072 , US-A-6196223 , WO-A-2007/068044 and WO-A-2012/064152 discloses a face mask seal.
  • Some existing FFRs use some form of an adhesive to attach the face seal directly to the user's face.
  • US-A-6125849 (Williams ) is one such example.
  • US-A-8381727 (Matich ) which describes a mask with a FS comprised of an endless skin adhesive seal on the inside of the covering, with multiple such adhesive seals applied to each other and the inside of the mask shell perimeter.
  • the authors provide examples of fit factors (FFs) determined by scientific measuring protocols and methods that are well to known to those reasonably skilled in the prior art.
  • FSIL is difficult to reduce because of the significant variances in human facial anatomy.
  • Anthropometric studies have revealed the substantial differences in the multiple variables of human facial anatomy. These are notable, perhaps not coincidentally, in the three areas that are common for FSILs to occur: 1) the nasal bridge and the cheek bone, 2) the cheek bone to the edge of the lower jaw, and 3) around and under the area between the undersurface of the chin back toward the angle of the jaw.
  • the problem of FSIL may also be compounded by FFRs being made in fairly generic "small, medium, and large” sizes, and often simply as a "one size fits all" design. Therefore it can be seen that for existing FFRs:
  • the present invention provides a face mask seal to be used to provide a seal between the wearer's face and a face mask respirator of any design, said face mask seal comprising:
  • the present invention differs substantially from those face seals of the prior art in that all of the areas of human facial anatomy, and of face seal designs of the prior art that are known to be involved in FSIL, have been addressed individually and specifically with unique design features in both geometry and material composition.
  • Critical Fit Zone I the area bordered by the Rhinion- Osseocartilaginous Junction, or “Nasal Bridge” along the NasoMaxiliary Ridge/Process, the Maxillary Zygomatic Ridge, and on to the Zygomatic Process (forward ridge "cheek bone”).
  • Critical Fit Zone II the area starting at the Zygomatic Process, along the Bucchal Wall Soft Tissue Structures and on to the Mandibular Ramus, Body, Inferior Rim.
  • “Critical Fit Zone III” the area starting at the Mandibular Ramus, Body, Inferior Rim, along the area on both sides of the under surface of the face, and the Submental Soft Tissues across to the opposite Mandibular Ramus, Body, Inferior Rim.
  • Standard Laboratory means a testing setup and method in an artificially controlled environment.
  • FF means a Fit Factor as determined by experimental protocols consistent with those as described in OSHA Respirator Standard, 29 CFR 1910.134.
  • FFoverall means a computation based on FFs during each of 8 fit test exercises consistent with those as described in OSHA Respirator Standard 29 CFR 1910.134.
  • FFR means a filtering facepiece respirator
  • Face Mask Perimeter means any or all points of contact between any aspect of a FM, a FFR, a half face mask elastomeric respirator, or a full face mask elastomeric respirator, and the corresponding surfaces of the human face.
  • FS means a seal, or an area intended to function as a seal, on a FM, a FFR, a half face mask elastomeric respirator, or a full face mask elastomeric respirator, that is intended to prevent inhaled and/or exhaled particulate matter, or gaseous vapors, from leaking between the perimeter edges of such masks or respirators, and the corresponding surfaces of the human face that said perimeter edges come in contact with, which thereby allows said particulate matter, or gaseous vapors, to bypass the filtering elements of said masks or respirators.
  • FSIL means leakage of inhaled and/or exhaled particulate matter, or gaseous vapors, from outside of a FM, a FFR, a half face mask elastomeric respirator, or a full face mask elastomeric respirator, being worn by a user, to the inside of the said mask or respirator, between the perimeter edge of such mask or respirator---where said perimeter edge is intended to function as the FS on said mask or respirator, and the corresponding surfaces of the human face to which said perimeter edge comes in contact with in any way, resulting in said particulate matter, or gaseous vapors, bypassing the said mask or respirator's filter element.
  • GM means Geometric Mean.
  • GSD Geometric Standard Deviation
  • Heated means a version of the FS composed of a material, or materials, that is designed to be thermally activated in order to be custom-fitted to the user's face, and is being used in its thermally activated state.
  • IL means the total amount of leakage of inhaled and/or exhaled particulate matter, or gaseous vapors, from outside of a FM, a FFR, a half face mask elastomeric respirator, or a full face mask elastomeric respirator, being worn by a user, to the inside of said mask or respirator, resulting in said particulate matter, or gaseous vapors, bypassing the said mask or respirator's filter elements.
  • Not Heated means a version of the FS composed of a material, or materials, that is designed to be thermally activated in order to be custom-fitted to the user's face, and is being used in its non-thermally activated state.
  • Prototype means any N100 FFR herein described with its stock FS removed and replaced with embodiments herein described.
  • Report means the work presented herein and in its entirety.
  • Wash means the form of the device as it is made commercially, or otherwise, available.
  • SWPF Simulated Workplace Protection factor, which has an FFoverall based on studies performed in an environment designed to equal as closely as possible the conditions that would be encountered in the work place setting where the intended use of the FFR would take place.
  • WPF Workplace Protective Factor, which has an FFoverall based on studies performed in the actual environment where the intended use of the FFR would take place.
  • Fig. 1 illustrates the three Critical Fit Zones (CFZs) of the human face involved in FSIL and as defined herein by : "CFZ-1" 9 being the area bordered by the Rhinion-Osseocartilaginous Junction, or "Nasal Bridge” 1, along the NasoMaxiliary Ridge/Process 2, the Maxillary Zygomatic Ridge 3, and on to the Zygomatic Process (forward ridge "cheek bone”) 4; “CFZ-2” 10 being the area from the Zygomatic Process (forward ridge "cheek bone”) 4 along the Bucchal Wall Soft Tissue Structures 5 and on to the Mandibular Ramus, Body, Inferior Rim 6; and; “CFZ-3” 11 being the area from the Mandibular Ramus, Body, Inferior Rim 6 on one side of the face, and the Submental Soft Tissues 7 in the zone from one portion of the inferior rim 6 across to the Mandibular Ramus, Body, Inferior Rim 6 on
  • Fig. 2 illustrates the view of the inside of a typical face mask 12 of the prior art.
  • Each of the CFZs 9, 10, 11 corresponding to anatomic components 1, 2, 3, 4, 5, 6, 7 is illustrated as it relates to the corresponding regions along the inside perimeter of the mask shell 12.
  • Fig. 3 illustrates a FS 13 and is provided for comparative purposes only.
  • CFZs 9, 10, 11 have each been compensated for by specific and substantial corresponding convex accentuations 14, 15, 16 along the inner perimeter 13b of FS 13.
  • Each accentuation involves a convex curved reciprocal portion that extends into the corresponding CFZ zone 9, 10, 11 of the human face that will come in contact with the FS 13 upon wearing of the mask 12.
  • the region of 9 has been shown in anthropometric studies to be the shortest perimeter section of the three CFZ regions 9, 10, 11, and also possessing the deepest concavity of CFZs 9, 10, 11.
  • Region 14 of FS 13 is correspondingly the shortest, and has the most convex accentuation, of regions 14, 15, 16 of the FS 13.
  • CFZs 10 and 11 are known to be similar in length and depth along the human face, although there is a slightly greater distance involved in CFZ 11 than in CFZ 10. Therefore the corresponding areas 14, 15, 16 of the FS 13 herein are designed to be compensating for these slight differences.
  • the areas 14, 15, 16 may be further modified to conform to, compensate and reciprocate for, the CFZs 9, 10, 11 above. There may be additional anatomically defined corresponding accentuations of the FS 13 at points other than, or in addition to, areas 14, 15, 16.
  • the areas 14, 15, 16 may be custom-configured to the user's facial features comprised within CFZs 9, 10, 11 by being cut from an image guided, computer generated pattern that is unique to the user's face.
  • any methodology of custom cutting the FS 13 and yielding areas 14, 15, 16 corresponding to CFZs 9, 10, 11 can be utilized to yield the FS 13 as described above.
  • the material used may be thermoplastic copolymer foam.
  • One such thermoplastic copolymer foam may be ethylene vinyl acetate (EVA).
  • EVA ethylene vinyl acetate
  • the material used may be a solid thermoplastic copolymer.
  • One such solid thermoplastic copolymer may be ethylene vinyl acetate (EVA).
  • EVA ethylene vinyl acetate
  • many such solid thermoplastic copolymers are applicable and are well known to those familiar with the prior state of the art.
  • the material used may be heat activated thermoplastic copolymer foam which can be actively molded to a user's face.
  • One such heat activated thermoplastic copolymer foam may be ethylene vinyl acetate (EVA).
  • EVA ethylene vinyl acetate
  • many such heat activated thermoplastic copolymer foams are applicable and well known to those familiar with the prior state of the art.
  • the material used may be a solid heat activated thermoplastic copolymer.
  • One such solid heat activated thermoplastic copolymer may be ethylene vinyl acetate (EVA).
  • EVA ethylene vinyl acetate
  • the material used may pressure activated.
  • the material used may be cold activated.
  • the material used may be a viscoelastic copolymer foam.
  • the material used may be solid viscoelastic copolymer.
  • the thickness of the material may be anywhere from 1/16 inch up to 1 ⁇ 2 inch. It should be noted that any thickness of the FS 13 material can be utilized in so far as it allows for the same, or similar, performances in the testing results as discussed further herein.
  • Fig. 3A illustrates a hypothetical longitudinal plane of bisection 13c through FS 13.
  • Fig. 3B illustrates a horizontal cross sectional view of an example of a different version of the FS 13 which is shown as FS 13d and is an embodiment of the invention.
  • the cross sectional view of both FS 13 and FS 13d is at the point of bisection plane 13c as illustrated in Fig. 3A .
  • Both FS 13 and FS 13d have the same three parallel points of transection demonstrated by vertical planes 14a, 15a, 16a at the maximum convex accentuations of areas 14, 15, 16 and areas 14b, 15b, 15b respectively. It can be seem that both FS 13 and FS 13d have identical convex accentuations of their respective inner perimeters 13b and 13e respectively, at locations indicated at 14, 15, 16 and 14b, 15b, 16b respectively.
  • the thickness of inner perimeter 13b of FS 13 at points 14c, 15c, 16c can be seen as equal to each other, and equal to the rest of the perimeter 13b of FS 13.
  • FS 13d has in the same three longitudinal planes of bisection, additional accentuations along perimeter 13e of FS 13d, at points 14d, 15d, 16d that are perpendicular to the areas 14b, 15b, 16b.
  • the additional perpendicular accentuations along perimeter 13e of FS 13d, at points 14d, 15d, 16d may be seen as an increased thickness of the inner perimeter 13e at these locations versus the thickness of the rest of the inner perimeter 13e of FS 13d.
  • FS 13d may be made additionally thicker at areas 14b, 15b, 16b, along inner perimeter 13e, by adding further convex accentuations that are perpendicular to the axis of 13e, which are seen at points 14d, 15d, 16d along the inside perimeter 13e, of FS 13d.
  • areas 14d, 15d, 16d of inner perimeter 13e may be thinner than the rest of the perimeter 13e.
  • Fig. 4 illustrates the FS 13 described in Fig. 3 affixed to mask 12, being a typical cup shaped FFR of the variety that are well known to those familiar with the present state of the art.
  • the mask 12 design may be of a rectangular configuration.
  • the mask 12 design may be of a generalized facial form fitting configuration.
  • the outer perimeter 13a of FS 13 can be configured to be affixed to the corresponding outer perimeter of any such FFR known to those familiar with the present state of the art.
  • the entire FS 13 may be incorporated into the construction of the body of the mask 12.
  • the FS 13 can be configured to be incorporated into either the corresponding outer perimeter of, or the body of, any such FFR known to those familiar with the present state of the art.
  • FS 13 can be affixed to, or incorporated into the design of a mask 12 which may be of a half mask respirator design.
  • FS 13 can be affixed to, or incorporated into the design of, a mask 12 which may be of a full mask respirator design.
  • FS 13 can be affixed to, or incorporated into, any form of device that is intended to either protect and/or cover part or all of the human face.
  • Such applications for the FS 13 can include face goggles for skiing, aquatic sports face goggles, motorcycle goggles, aviation face goggles, military respirators, and first responder respirators. It should be noted that this list is not intended to be all-inclusive.
  • Fig. 5 illustrates the method used to achieve heat-activation of the FS 13 in all studies presented herein.
  • fixation of the FS 13 to N100 mask 17 was done with a heat-resistant silicon based adhesive (TW Permatex Inc., Solon, Ohio). Twelve hours were allowed for drying time of FS 13 to mask 17.
  • a standard heat gun (Ryobo Mod. HG600, One World Technologies, Inc., Anderson, OH) was used at set temperature of 500Fdeg.
  • the temperature of the heat source can be less than about 100 °F, about 100 °F, 200 °F, 300 °F, 400 °F, 500 °F, or greater, or any temperature therebetween.
  • the gun was held at a distance of 2in from the surface face of FS 13. Using constant motion around the surface face of FS 13, the heating was carried out for approximately 2 minutes ( Fig. 5a ). In the case of the EVA foam, a distinct transition in the surface appearance occurred from that of a flat back to having a glossier black characteristic.
  • the distance of the heat source from the surface of FS 13 can be less than about 1 inch, 1 inch, 2 inches, 3 inches, 4 inches, 5 inches, 6 inches, 1 foot, 2 feet, or more, or any distance therebetween.
  • the time for applying the heat may be less than about 30 seconds, about 1 minute, 1.5 minutes, 2 minutes, 3 minutes, 4 minutes, 5 minutes, or more, or any time therebetween.
  • the FS 13 can be heated to less than about 50 °F, 60 °F, 70 °F, 80 °F, 90 °F, 100 °F, 110 °F, 120 °F, or more, or any temperature therebetween.
  • the mask 17 with FS 13 was then positioned on the user's face, by the user, and the holding straps were adjusted to obtain a secure fit, in compliance with OSHA's to 29CFR1910.134: Part I. OSHA-Accepted Fit Test Protocols; Appendix A, pp. 1-13. ( Fig. 5b ). After 90 seconds of cooling time, testing was begun.
  • Fig. 6 illustrates the laboratory test environment used, which has been widely described for research in the present state of the art (Balazy et al. 2006, Lee, et al, 2004, Choe et al 2000, Grinshpun et al. 2004, Lee et al 2008).
  • a walk-in indoor test chamber (860 ft3 24.3 m3) was utilized to conduct the initial study. The test chamber was maintained at a positive pressure of 1 in. w.g. (249 Pa) during the experiments.
  • Sodium chloride solution (NaCl, 1%, w/v) was aerosolized in the chamber by a six-hole collision nebulizer (BGI Inc., Waltham, MA, USA) at a pressure of 20 psi (1.38 x 10 5 Pa) and a flow rate of 12 l/min. Dry air was mixed with NaCl aerosols at a flow rate of 40 l/min. NaCl was used as a primary test aerosol at concentrations ranging from 4.2 x 107 to 1.9 x 108 particles/ m3.
  • the FS 13 was heat-activated according the protocol as set forth above in Fig. 5 .
  • a single human subject then performed the quantitative fit testing, which was conducted with a TSI P-TRAK (TSI, Inc., St. Paul, MN, USA) optical particle counter (OPC), with customized software in order to obtain fit factors >200. Samples were obtained outside the mask (ambient air) and inside the mask via customized fittings placed centrally on the mask to which tubing connected the samples to separate OPC's.
  • TSI P-TRAK TSI, Inc., St. Paul, MN, USA
  • OPC optical particle counter
  • Fit-testing exercises were performed according to the OSHA 29CFR1910.134, Part 1; Appendix A, Sec 14a "Test exercises", pp. 1-8. These exercises include normal breathing, deep breathing, turning the head from side to side, moving the head up and down, talking, grimace maneuver, bending over and touching the toes, and returning to normal breathing (US Department of Labor, 1998). Each exercise was performed for 2 min (versus OSHA's 1-min protocol) and the particle concentrations inside and outside the respirator were averaged over 1-min periods. The challenge NaCl aerosol concentrations were measured inside the Mask 17 and outside Mask 17.
  • the concentration inside the respirator (c-in) for the entire test was averaged over all the exercises, excluding the grimace maneuver.
  • the particle concentrations outside the respirator (c-out) were measured at the beginning, middle and end of the test. The average of these concentrations was used as the concentration outside the respirator for each test.
  • the data analysis was performed using an analysis of variance (ANOVA) model provided by the Statistical Analysis System version 8.0 (SAS Institute Inc., Cary, NC, USA). P-values of 0.05 were considered significant.
  • the difference in mean FFs among nine surgical masks was examined by the ANOVA followed by a pairwise comparison using the Tukey's studentized range test. This statistical method was also used to examine the difference in the PFs among different particle sizes.
  • the FS 13 was composed of EVA foam (McMaster-Carr, Robbinsville, NJ).
  • the same labeling index applies to Control Model B N100FFR and all prototype versions of mask 17 thereof, and as described herein.
  • Control FFR 17 stock FS was removed and the FS 13 was affixed to the inner periphery of mask 17 according to the protocol described in Fig. 5 .
  • Control-B performed better than the Control-A.
  • the overall fit factor (FFoverall) of the Control-A was below 100; for the Control-B, the FFoverall exhibited geometric mean(GM) slightly higher than the targeted OSHA threshold of 100.
  • the [A+Proto3/8FS]13 showed an improved overall FF: over 100-fold greater than the non-modified Control-Aand 6-fold greater than the previously tested [A+Proto1 ⁇ 4FS]13.
  • the level is not as high as [B+Proto3/8FS] 13(see below), but it's greater than 3,300 (min FF for the N100 filter), which suggests either no FSIL, or extremely small FSIL(with the leak penetration lower than or comparable to the filter penetration).
  • Fig. 7 illustrates the setup for the Simulated Workplace Protective Factor(SWPF) study performed in a teaching university hospital surgical laboratory setting.
  • SWPF Simulated Workplace Protective Factor
  • the study surgeon (an experienced board certified general surgeon) positioned himself at a customary distance from the surgical site.
  • the electrosurgical generator unit (Valleylab Force FX, Covidien, Boulder, CO) was set at a blend current of 40wts.
  • a standard electrosurgical pencil (Valleylab E2516, Covidien, Boulder, CO) was used.
  • the surgical smoke plume was suctioned at a customary distance by an experienced surgical assistant.
  • OPC placement, and tubing fixation to each mask tested was identical to the protocol as shown in Fig. 6 .
  • the OPC measuring the ambient air was modified to be able to function with what proved to be extremely high particle counts in the surgical smoke plume.
  • a 1/10 dilution was used when the ambient concentration was expected to be greater than 500,000 particles per cm3, which is the upper threshold of the P-TRAK.
  • the mask 17 used was identical to the Model-B N100 FFR as detailed in Fig. 6 above.
  • the FS 13 was of the 3/8in thickness for this study, and for all remaining study examples reported herein.
  • Each version of the mask 17 was tested in triplicate: mask 17 with its stock FS; mask 17 with the stock FS removed and replaced with the FS 13 and not heated; mask 17 with the stock FS removed and replaced with the FS 13 and heated prior to use. Fixation of the FS 13 to the mask 17 was by the process detailed in Fig. 5 . Heat activation of FS 13 was performed as detailed in Fig. 5 , with the exception that the mask was held in place on the user's face, by the user, and the retaining straps placed and secured after, rather than before, the 90 second cooling period.
  • Figures 9-11 are results of the SWPF studies done as described in Fig. 7 , and represent examples of the time series for the aerosol concentrations outside the respirator (ambient) and inside the respirator (mask) measured with a OPC in the operating room with the three study mask 17 versions: the Control-B; the NON-HEATED Prototype; the HEATED Prototype
  • Figure 12 represents SWPFs determined based on the OPC measurements in the operating room for the three mask 17 versions (the data from 12 tests were summarized). The bars represent GMs; the error bars represent standard deviations.
  • Figure 13 represents numerical data for the SWPF values calculated using the time-weighted average concentration values for respirators 1, 4, 7, 10 (Control-B); 2, 8, 11 (NON-HEATED Prototype); and 3, 6, 9, 12, 13 (HEATED Prototype).
  • the GMs and geometric standard deviations(GSD) are used in Figure 12 above.
  • Four Control-B FFRs produced different SWPFs with 3 out of 4 above 100 and the GM-value close to 100. All three SWPFs produced by the NON-HEATED Prototypes were above 3,300 (the N100 filter can allow to penetrate 0.03% of particles which translates to (SWPF filter)min ⁇ 3,300; thus, any value in excess of 3,300 can technically represent a "perfectly fit" mask, i.e., the mask for which no measurable face seal leakage was identified.
  • the difference between the NON-HEATED Prototypes and the HEATED Prototype data sets was statistically significant (p 0.0118).
  • the somewhat lower-than-expected performance of the HEATED Prototype was attributed to the leakage created due to the respirator re-donning (the following sequence was applied: heating, donning, taking off, re-donning). This part of the protocol deviated from the previous fit testing protocol as detailed in Fig. 5 , and as used in Fig 6 , Example 1.
  • Figure 14 represents an experimental study design with the same setup as seen in Fig. 6 and as reported in Example-1.
  • the human subject was the same as that in Example-2 above, and hence different from Example-1.
  • the same heating protocol for FS 13 as in Example-1 was utilized, as described in Fig. 5 : after heating, the mask was placed to the face and straps secured, followed by the 90 second cooling period.
  • the GM FFoverall of the HEATED and NON-HEATED Prototypes in this study are nearly identical, although the highest FFoverall was with the HEATED Prototype.
  • the same subject in Example-2, with the same Control-B mask and the same Prototype Masks with FSs 13 had a greater difference in the GM FFoverall between the NON-HEATED Prototypes (higher) and the HEATED Prototypes (lower).
  • the subject in Example-1 however, had significantly higher GM FFoveralls for the HEATED Prototypes than for the NON-HEATED Prototypes.
  • Example 2 This study setup was essentially the same as seen in Example 2, with three exceptions: 1) a section of animal tissue was used rather than a live animal; 2) the study took place in a fully functional hospital operating room with temperature and humidity controls as well as standard negative air flow; 3) three human study participants were used: the two participants involved in Example 1 and Example 2 & 3, and a third study participant. It should be noted that the anthropometrics of each participant's facial anatomy was significantly different, and that the first two participants were male and the third participant was female. Thus this study represented a true WPF design.
  • the OPC measuring the ambient air was modified to be able function with what proved to be extremely high particle counts in the surgical smoke plume.
  • a 1/10 dilution was used when the ambient concentration was expected to be greater than 500,000 particles per cm3, which is the upper threshold of the P-TRAK.
  • the heating protocol was used as described in Fig. 5 , and as used in Examples 1 & 3 above. There were three subjects, three replicate tests per subject, and a randomized design was applied. For each test, a representative time segment was determined to compare the ambient and in-mask time-averaged aerosol concentrations taken from the time series (in most cases, a continuous monitoring period exceeded 1 min).
  • Figure 16 represents individual mask's GMs and GSDs for each mask version tested.
  • Figure 17 represents statistical analysis p-values for the Control-B masks as compared to the NON-HEATED and HEATED Prototypes.
  • Figure 18 represents an example of the particle counts during the minute testing of a NON-HEATED Prototype mask, comparing ambient air counts versus inside mask counts.
  • Figure 19 represents a graphical presentation of the protection level determined for the three respirator masks 17 versions---Control-B, NON-HEATED Prototype, and HEATED Prototype---as worn by the three subjects with three replicate tests per subject.
  • the Control-B mask showed a proper fit only 5 times out of 9 (with WPF>100); it exhibited the WPF values ranging from 11.5 to 1,442 with GM of 145.6 and a GSD of 2.1.
  • the NON-HEATED Prototypes fitted all 9 times out of 9 (with WPF>>100); they exhibited WPF values ranging from 6,494 to 67,185 with a GM of 21,262 and a GSD of 1.5 (narrower, i.e. more consistent than the control model).
  • the HEATED Prototypes fitted all 9 times out of 9 (with WPF>>100); they exhibited WPF values ranging from 4,584 to 112,502 with a geometric mean GM of 24,923 and a GSD of 1.6.
  • the GM of WPFs of the HEATED Prototype is about 15% greater than that of the NON-HEATED Prototype; however, this difference is not statistically significant (p>0.05).
  • the two types of the FS 13 prototype FFRs exhibited similar performance characteristics (both demonstrated much superior protection levels than the Control B N100 Mask FFR.

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Claims (14)

  1. Joint d'étanchéité pour masque facial (13d) à utiliser pour assurer l'étanchéité entre le visage du porteur et un masque respiratoire de n'importe quelle conception (17), ledit joint d'étanchéité pour masque facial comprenant :
    un périmètre interne (13e) ayant des accentuations convexes (14b, 15b, 16b) conçues spécifiquement pour se conformer à, correspondre à et compenser les caractéristiques anatomiques spécifiques correspondantes du visage humain (8) qui comporte
    une première zone d'ajustement critique (9) qui est délimitée par la jonction ostéo-cartilagineuse rhinion, ou le "pont nasal" (1), le long de la crête/processus naso-maxillaire (2), la crête zygomatique maxillaire (3) et sur le processus zygomatique (crête avant) (4) ;
    une deuxième zone d'ajustement critique (10) qui est la surface allant de la proéminence zygomatique, ou «les pommettes», le long des structures de tissu mou de paroi buccale (5) et sur la branche montante, corps, bord inférieur de la mandibule (6) ; et
    une troisième zone d'ajustement critique (11) qui est la surface allant de la branche montante, corps, bord inférieur de la mandibule (6) sur les deux côtés de la surface inférieure du visage, et les tissus mous sous-mentonniers (7) dans cette zone,
    où chacune des accentuations convexes (14b, 15b, 16b) est une partie correspondante courbée convexe du périmètre interne (13e),
    caractérisé en ce qu'au niveau des trois accentuations convexes maximales (14b, 15b, 16b) il y a des accentuations convexes supplémentaires (14d, 15d, 16d) du périmètre interne (13e) qui sont perpendiculaires aux accentuations convexes maximales (14b, 15b, 16b) et représentent une épaisseur accrue du périmètre interne (13e) par rapport à l'épaisseur du reste du périmètre interne (13e).
  2. Joint d'étanchéité pour masque facial (13d) de la revendication 1, comprenant des accentuations convexes supplémentaires (14d, 15d, 16d) du périmètre interne (13e) qui sont perpendiculaires à l'axe du périmètre interne (13e) et qui compensent les première, deuxième et troisième zones d'ajustement critiques (9, 10, 11).
  3. Joint d'étanchéité pour masque facial (13d) de la revendication 1 ou 2, qui est :
    activé par la chaleur et moulé sur le visage du porteur avec le joint d'étanchéité attaché au masque,
    activé par la chaleur et moulé sur le visage du porteur avec le joint d'étanchéité non attaché au masque,
    activé par la pression et moulé sur le visage du porteur avec le joint d'étanchéité attaché au masque,
    activé par la pression et moulé sur le visage du porteur avec le joint d'étanchéité non attaché au masque,
    activé chimiquement de manière quelconque et moulé sur le visage du porteur avec le joint d'étanchéité attaché au masque,
    activé chimiquement de manière quelconque et moulé sur le visage du porteur avec le joint d'étanchéité non attaché au masque.
  4. Joint d'étanchéité pour masque facial (13d) des revendications 1 à 3, dans lequel un périmètre externe (13a) est attaché à un masque respiratoire formant un joint d'étanchéité essentiellement étanche à l'air entre le masque respiratoire et le périmètre externe (13a).
  5. Joint d'étanchéité pour masque facial (13d) des revendications 1 à 4, qui est réalisé en un copolymère thermoplastique, un copolymère élastomère ou un copolymère élastomère thermoplastique.
  6. Joint d'étanchéité pour masque facial (13d) de la revendication 5, comprenant de l'éthylène-acétate de vinyle (EVA).
  7. Joint d'étanchéité pour masque facial (13d) des revendications 1 à 6 utilisé sur :
    un demi-masque respiratoire,
    un masque respiratoire intégral,
    un masque respiratoire à élément filtrant,
    un masque respiratoire militaire intégral,
    un masque respiratoire militaire à élément filtrant,
    un respirateur ou masque quelconque conçu pour protéger le porteur ou l'environnement d'une matière particulaire d'un matériau non biologique, biologique ou chimique ou
    un respirateur ou masque quelconque conçu pour protéger le porteur ou l'environnement des vapeurs d'un matériau non biologique, biologique ou chimique.
  8. Joint d'étanchéité pour masque facial (13d) de la revendication 1, dans lequel la géométrie de joint d'étanchéité pour masque facial est personnalisée à partir d'un motif propre au visage de l'utilisateur individuel.
  9. Joint d'étanchéité pour masque facial (13d) de la revendication 8, dans lequel le joint d'étanchéité pour masque facial (13d) est réutilisable.
  10. Joint d'étanchéité pour masque facial (13d) des revendications 1 à 9, utilisé sur des masques faciaux destinés à être utilisés dans des activités de loisirs.
  11. Joint d'étanchéité pour masque facial (13d) des revendications 1 à 10, utilisé pour des lunettes de ski, des masques de plongée autonome, des lunettes de parachutisme, des lunettes de moto, des lunettes de natation ou un masque de sommeil.
  12. Procédé destiné à assurer l'étanchéité d'un masque facial consistant à :
    fournir le joint d'étanchéité pour masque facial (13d) de la revendication 1 ;
    chauffer le joint d'étanchéité pour masque facial (13d) pendant une durée prédéterminée ;
    positionner la paire d'accentuations convexes (14) sur la jonction ostéo-ocartilagineuse rhinion (1) du visage d'un porteur ;
    fournir une pression au joint d'étanchéité pour masque facial (13d) afin de déformer la paire d'accentuations convexes (14) sur la jonction ostéo-ocartilagineuse rhinion (1) du visage du porteur ; et
    retenir le joint d'étanchéité pour masque facial (13d) sur la jonction ostéo-ocartilagineuse Rrinion (1) du visage du porteur pendant une durée prédéterminée.
  13. Procédé de la revendication 12, dans lequel la durée prédéterminée pour chauffer le joint d'étanchéité pour masque facial (13d) est d'environ 2 minutes.
  14. Procédé de la revendication 12, dans lequel la durée prédéterminée pour retenir le joint d'étanchéité pour masque facial (13d) est d'environ 2 minutes.
EP14752518.2A 2013-08-08 2014-07-30 Joint d'étanchéité pour masque facial destiné à être utilisé avec des dispositifs respiratoires et des masques chirurgicaux, à géométrie définie de manière anatomique conformément à des régions critiques de l'anatomie faciale humaine, et pouvant être adapté sur mesure et de manière active au visage de l'utilisateur Active EP3030099B1 (fr)

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US20150040910A1 (en) 2015-02-12
CN105636468A (zh) 2016-06-01
US10207129B2 (en) 2019-02-19
EP3030099A1 (fr) 2016-06-15
US9468782B2 (en) 2016-10-18
WO2015020857A1 (fr) 2015-02-12
US20150367151A1 (en) 2015-12-24
CA2938424A1 (fr) 2015-02-12
CN105636468B (zh) 2017-08-29
BR112016002769A2 (pt) 2017-08-01
HK1225925B (en) 2017-09-22

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